QC Microbiology Specialist - Method Validation and NPI

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 70,000 - 100,000; Part time

Job summary

BioPharma Consulting JAD Group is seeking a technical specialist for a microbiology lab in Juncos, Puerto Rico. You will support method validations for new product introductions and provide expert guidance on bioburden, endotoxin and mycoplasma testing.

The role requires a strong microbiology background, experience with MMV and technical writing, and knowledge of GMP/GLP. Bilingual English/Spanish is preferred. Contract: 2.5 months with potential extension.

Qualifications

• Bachelor's degree plus 4 years of relevant microbiology experience.
• Experience with microbiology method validation and technical writing.
• Experience with bioburden, endotoxin, sterility, MMV, mycoplasma testing.
• Strong knowledge of GMPs/CFRs and U.S. regulations for testing biological products.
• Data analysis and trend analysis; problem solving.
• English/Spanish bilingual preferred.

Responsibilities

• Write MMV protocols and reports for new product introductions.
• Provide technical support to microbiology lab for bioburden, endotoxin, low endotoxin recovery, sterility and mycoplasma testing.
• Design special studies and troubleshoot assays.
• Support deviation owners in evaluating events and root causes; approve lab investigations.
• Develop, revise and audit controlled documents and support lab compliance with GMP/GLP.

Skills

Method validation

Technical writing

Data analysis

Bilingual English/Spanish

Education

Bachelor's degree in microbiology or related

Master's degree in microbiology

Doctorate in related field

Job description

Be the technical specialist for the microbiology lab at a leading biotechnology company in Juncos, Puerto Rico, supporting method validations for new product introductions.

What you'll do

• Write microbiology method validation (MMV) protocols and reports for new product introductions.
• Provide technical support to the microbiology lab: bioburden, endotoxin, low endotoxin recovery, sterility and mycoplasma testing.
• Design special studies and troubleshoot assays.
• Support deviation owners in evaluating events and root causes; approve lab investigations.
• Develop, revise and audit controlled documents and support lab compliance with GMP/GLP.

• Bachelor's + 4 years (or Master's + 2, or Doctorate) of directly related experience; microbiology background preferred.
• Microbiology method validation and technical writing.
• Bioburden, endotoxin (including low endotoxin recovery), sterility, MMV and mycoplasma testing.
• Strong knowledge of GMPs/CFRs and U.S. regulations for testing biological products.
• Data analysis, trending and complex problem solving.
• Bilingual English/Spanish preferred.

• Contract: 2.5 months, with possible extension
• Shift: Administrative, Monday–Friday 8:00 am–5:00 pm (overtime upon business needs)